Recall Z-0501-2025— OrganOx Ltd
Class II · Ongoing
Class II FDA medical device recall by OrganOx Ltd, initiated 2024-10-15. FDA's recall record names no specific 510(k) clearance for this event. Product: OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D0003 The OrganOx metra is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours.. Reason: Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket.
- Recalling firm
- OrganOx Ltd
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-15
- Firm location
- Oxford, N/A, United Kingdom
Product description
OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D0003 The OrganOx metra is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours.
Reason for recall
Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket
Data sourced from openFDA. This site is unofficial and independent of the FDA.